Health Promotion for Women With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00596674

Recruitment Status :
Completed

First Posted : January 17, 2008

Last Update Posted : April 25, 2012

Sponsor:

University of Texas at Austin

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a wide variety of disease-related, intrapersonal, and environmental demands to maintain their health and quality of life. Engaging in health-promoting behaviors is one strategy recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The purpose of this four-year study is to refine and test a theoretically and empirically based intervention to promote the health and well being of women with the chronic disabling condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle Counts" Intervention will report more greater self-efficacy for health behaviors, more frequent health behaviors and more positive health and quality of life than women in the comparison group.

Condition or disease

Intervention/treatment

Phase

Fibromyalgia

Behavioral: Lifestyle CountsOther: Attention Control

Not Applicable

Detailed Description:

This wellness intervention, originally developed and tested in a randomized clinical trial of women with MS (N=113), resulted in significant improvements in self-efficacy, health behaviors and improvements in pain, social functioning, mental health and emotional role-functioning. The specific aims of this study are to examine the effects of the adapted wellness intervention on self-efficacy, resources, barriers, health behaviors and health outcomes for women with fibromyalgia.

A sample of 160 women with FMS will be recruited to participate in a randomized clinical study to determine the effects of this wellness intervention that includes an eight week health promotion/behavior change component and 3 months of follow-up phone support. Content regarding stress management, lifestyle adjustment, physical activity, nutrition and women's health issues will be presented with an emphasis on the unique adaptations and associated skills required to empower women with the tools for exercising personal control over their health behaviors. The effects of the intervention on outcome variables will be assessed over an 8-month period with measurements at baseline, 2 months (immediately after the educational/skill-building component), 5 months (after 3 months of phone support) and at 8 months.

A wellness intervention that includes 8 weeks of behavior change classes focused on acquiring the skills and knowledge to improve health behaviors (e.g., exercise, stress management), followed by 3 months of phone support.

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Ages Eligible for Study:

18 Years to 75 Years (Adult, Older Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Female

Physician verified diagnosis of Fibromyalgia for at least 6 months, age 18 to 75,

Able to speak and read English

Willing to participate in 8-month intervention study

Exclusion Criteria:

Pregnancy

Male

Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated